Implanon

"Nov. 20, 2012 -- Oral contraceptives should be made available without a prescription to reduce unintended pregnancies, according to a newly published opinion by the American College of Obstetricians and Gynecologists (ACOG).

Implanon

INDICATIONS

DOSAGE AND ADMINISTRATION

The efficacy of IMPLANON does not depend on daily, weekly
or monthly administration.

All healthcare providers should receive instruction and
training prior to performing insertion and/or removal of IMPLANON.

A single IMPLANON implant is inserted subdermally in the
upper arm. To reduce the risk of neural or vascular injury, the implant should
be inserted at the inner side of the non-dominant upper arm about 8-10 cm (3-4
inches) above the medial epicondyle of the humerus. The implant should be
inserted subdermally just under the skin to avoid the large blood vessels and
nerves that lie deeper in the subcutaneous tissues in the sulcus between the
triceps and biceps muscles. IMPLANON must be inserted by the expiration date
stated on the packaging. IMPLANON is a long-acting (up to 3 years), reversible,
hormonal contraceptive method. The implant must be removed by the end of the
third year and may be replaced by a new implant at the time of removal, if
continued contraceptive protection is desired.

Initiating Contraception With IMPLANON

IMPORTANT: Rule out pregnancy before inserting the
implant.

Timing of insertion depends on the woman's recent
contraceptive history, as follows:

No preceding hormonal contraceptive use in the past month

IMPLANON should be inserted between Day 1 (first day of
menstrual bleeding) and Day 5 of the menstrual cycle, even if the woman is
still bleeding.

If inserted as recommended, back-up contraception is not
necessary. If deviating from the recommended timing of insertion, the woman
should be advised to use a barrier method until 7 days after insertion. If
intercourse has already occurred, pregnancy should be excluded.

Switching contraceptive method to IMPLANON

Combination Hormonal Contraceptives

IMPLANON should preferably be inserted on the day after
the last active tablet of the previous combined oral contraceptive or on the
day of the removal of the vaginal ring or transdermal patch. At the latest,
IMPLANON should be inserted on the day following the usual tablet-free,
ring-free, patch-free or placebo tablet interval of the previous combined
hormonal contraceptive.

If inserted as recommended, back-up contraception is not
necessary. If deviating from the recommended timing of insertion, the woman
should be advised to use a barrier method until 7 days after insertion. If
intercourse has already occurred, pregnancy should be excluded.

Progestin-only Contraceptives

There are several types of progestin-only methods.
IMPLANON should be inserted as follows:

Injectable Contraceptives: Insert IMPLANON on the day the
next injection is due.

Minipill: A woman may switch to IMPLANON on any day of
the month. IMPLANON should be inserted within 24 hours after taking the last
tablet.

Contraceptive implant or intrauterine system (IUS):
Insert IMPLANON on the same day as the previous contraceptive implant or IUS is
removed.

If inserted as recommended, back-up contraception is not
necessary. If deviating from the recommended timing of insertion, the woman
should be advised to use a barrier method until 7 days after insertion. If
intercourse has already occurred, pregnancy should be excluded.

First Trimester: IMPLANON should be inserted within 5
days following a first trimester abortion or miscarriage.

Second Trimester: Insert IMPLANON between 21 to 28 days
following second trimester abortion or miscarriage.

If inserted as recommended, back-up contraception is not
necessary. If deviating from the recommended timing of insertion, the woman
should be advised to use a barrier method until 7 days after insertion. If
intercourse has already occurred, pregnancy should be excluded.

Not Breastfeeding: IMPLANON should be inserted between 21
to 28 days postpartum. If inserted as recommended, back-up contraception is not
necessary. If deviating from the recommended timing of insertion, the woman
should be advised to use a barrier method until 7 days after insertion. If
intercourse has already occurred, pregnancy should be excluded.

Breastfeeding: IMPLANON should be inserted after the
fourth postpartum week [see Use In Specific Populations]. The woman
should be advised to use a barrier method until 7 days after insertion. If
intercourse has already occurred, pregnancy should be excluded.

Insertion Of IMPLANON

The basis for successful use and subsequent removal of
IMPLANON is a correct and carefully performed subdermal insertion of the
single, rod-shaped implant in accordance with the instructions. Both the
healthcare provider and the woman should be able to feel the implant under the
skin after placement.

All healthcare providers performing insertions and/or
removals of IMPLANON should receive instructions and training prior to
inserting or removing the implant. Information concerning the insertion and
removal of IMPLANON will be sent upon request free of charge [1-877-IMPLANON
(1-877-467-5266)].

Preparation

Prior to inserting IMPLANON carefully read the
instructions for insertion as well as the full prescribing information.

Before insertion of IMPLANON, the healthcare provider
should confirm that:

The procedure used for
IMPLANON insertion is opposite from that of an injection. The obturator keeps
IMPLANON in place while the cannula is retracted. The obturator must remain
fixed in place while the cannula with needle is retracted from the arm. Do not
push the obturator.

Insertion Procedure

Step 1. Have the woman lie on
her back on the examination table with her non-dominant arm flexed at the elbow
and externally rotated so that her wrist is parallel to her ear or her hand is
positioned next to her head (Figure 2).

Figure 2

Step 2. Identify the insertion
site, which is at the inner side of the non-dominant upper arm about 8-10 cm
(3-4 inches) above the medial epicondyle of the humerus (Figure 3). The
implant should be inserted subdermally just under the skin to avoid the large
blood vessels and nerves that lie deeper in the subcutaneous tissue in the
sulcus between the triceps and biceps muscles [see WARNINGS AND
PRECAUTIONS].

Step 3. Make two marks with a
sterile marker: first, mark the spot where the etonogestrel implant will be
inserted, and second, mark a spot a few centimeters proximal to the first mark
(Figure 3). This second mark will later serve as a direction guide during
insertion.

Figure 3

Step 4. Clean the insertion
site with an antiseptic solution.

Step 5. Anesthetize the
insertion area (for example, with anesthetic spray or by injecting 2 mL of 1%
lidocaine just under the skin along the planned insertion tunnel).

Step 6. Remove the sterile
pre-loaded disposable IMPLANON applicator carrying the implant from its
blister. Keep the IMPLANON needle and rod sterile. The applicator should not be
used if sterility is in question. If contamination occurs, use a new package of
IMPLANON with a new sterile applicator.

Step 7. Keep the shield on the
needle and look for the IMPLANON rod, seen as a white cylinder inside the
needle tip.

Step 8. If you don't see the
IMPLANON rod, tap the top of the needle shield against a firm surface to bring
the implant into the needle tip.

Step 9. Following visual confirmation,
lower the IMPLANON rod back into the needle by tapping it back into the needle
tip. Then remove the needle shield, while holding the applicator upright.

Step 10. Note that IMPLANON
can fall out of the needle. Therefore, after you remove the needle shield,
keep the applicator in the upright position until the moment of insertion

Step 11. With your free hand,
stretch the skin around the insertion site with thumb and index finger (Figure
4).

Step 12. At a slight angle (not greater than 20°),
insert only the tip of the needle with the beveled side up into the insertion
site (Figure 5).

Figure 4

Step 13. Lower the applicator to a horizontal position.
Lift the skin up with the tip of the needle, but keep the needle in the subdermal
connective tissue (Figure 6).

Figure 5

Step 13. Lower the applicator to a horizontal position.
Lift the skin up with the tip of the needle, but keep the needle in the
subdermal connective tissue (Figure 6).

Figure 6

Step 14. While “tenting” (lifting) the skin, gently
insert the needle to its full length. Keep the needle parallel to the surface
of the skin during insertion (Figure 7).

Figure 7

Step 15. If IMPLANON is placed too deeply, the removal
process can be difficult or impossible. If the needle is not inserted to its
full length, the implant may protrude from the insertion site and fall out.

Step 16. Break the seal of the applicator by pressing the
obturator support (Figure 8).

Figure 8

Step 17. Turn the obturator 90° in either direction with respect to the needle
(Figure 9).

Figure 9

Step 18. While holding the
obturator fixed in place on the arm, fully retract the cannula (Figure 10). Note:
This procedure is opposite from an injection. Do not push the obturator. By
holding the obturator fixed in place on the arm and fully retracting the
cannula, the implant will be left in its correct subdermal position. Do not
simultaneously retract the obturator and cannula from the patient's arm.

Figure 10

In this figure, the right hand
is holding the obturator in place while the left hand is retracting the
cannula.

Step 19. Confirm that the
implant has been inserted by checking the tip of the needle for the absence of
the implant. After insertion of the implant, the grooved tip of the obturator
will be visible inside the needle (Figure 11).

Figure 11

Step 20. Always verify the presence of the implant in
the woman's arm immediately after insertion by palpation. By
palpating both ends of the implant, you should be able to confirm the presence
of the 4-cm rod (Figure 12).

Figure 12

If you cannot feel the implant
or are in doubt of its presence,

Check the tip of the needle for the absence of the implant. After
insertion of the implant, the grooved tip of the obturator will be visible
inside the needle.

Use other methods to confirm
the presence of the implant. Suitable methods to locate are: ultrasound (US) with a high-frequency linear array transducer (10 MHz or
greater) or magnetic resonance imaging (MRI). Please note that the IMPLANON rod
is not radiopaque and cannot be seen by X-ray or CT scan. If ultrasound and MRI
fail, call 1-877­IMPLANON (1-877-467-5266) for information on the procedure for
measuring etonogestrel blood levels.

Until the presence of the
implant has been verified, the woman should be advised to use a non-hormonal
contraceptive method, such as condoms.

Step 21. Place a small adhesive
bandage over the insertion site. Request that the woman palpate the implant.

Step 22. Apply a pressure
bandage with sterile gauze to minimize bruising. The woman may remove the
pressure bandage in 24 hours and the small bandage over the insertion site in 3
to 5 days.

Step 23. Complete the USER CARD
and give it to the woman to keep. Also, complete the PATIENT CHART LABEL and
affix it to the woman's medical record.

Step 24. The applicator is for
single use only and should be disposed in accordance with the Center for
Disease Control and Prevention guidelines for handling of hazardous waste.

Removal Of IMPLANON

Preparation

Before initiating the removal
procedure, the healthcare provider should carefully read the instructions for
removal and consult the USER CARD and/or the PATIENT CHART LABEL for the
location of the implant. The exact location of the implant in the arm should be
verified by palpation. If the implant is not palpable, ultrasound with a
high-frequency linear array transducer (10 MHz or greater) or magnetic
resonance imaging can be performed to verify its presence.

A non-palpable implant should
always be first located prior to removal. Suitable methods for localization
include ultrasound with a high-frequency linear array transducer (10 MHz or
greater) or magnetic resonance imaging. If these imaging methods fail to locate
the implant, etonogestrel blood level determination can be used for
verification of the presence of the implant. For details on etonogestrel blood
level determination, call 1-877-IMPLANON (1-877-467-5266) for further
instructions.

After localization of a
non-palpable implant, consider conducting removal with ultrasound guidance.

There have been occasional
reports of migration of the implant; usually this involves minor movement
relative to the original position. This may complicate localization of the
implant by palpation, ultrasound or magnetic resonance imaging, and removal may
require a larger incision and more time.

Exploratory surgery without
knowledge of the exact location of the implant is strongly discouraged. Removal of deeply
inserted implants should be conducted with caution in order to prevent injury
to deeper neural or vascular structures in the arm and be performed by
healthcare providers familiar with the anatomy of the arm.

Before removal of the implant,
the healthcare provider should confirm that:

The woman does not have
allergies to the antiseptic or anesthetic to be used.

Removal Procedure

Step 1. Clean the site where the incision will be made
and apply an antiseptic. Locate the implant by palpation and mark the distal
end (end closest to the elbow), for example, with a sterile marker (Figure 13).

Figure 13

Step 2. Anesthetize the arm, for example, with 0.5 to 1
mL 1% lidocaine at the marked site where the incision will be made (Figure 14).
Be sure to inject the local anesthetic under the implant to keep it close to
the skin surface.

Figure 14

Step 3. Push down the proximal end of the implant (Figure
15) to stabilize it; a bulge may appear indicating the distal end of the
implant. Starting at the distal tip of the implant, make a longitudinal
incision of 2 mm towards the elbow.

Figure 15

Step 4. Gently push the implant
towards the incision until the tip is visible. Grasp the implant with forceps
(preferably curved mosquito forceps) and gently remove the implant (Figure 16).

Figure 16

Step 5. If the implant is
encapsulated, make an incision into the tissue sheath and then remove the
implant with the forceps (Figures 17 and 18).

Figure 17

Figure 18

Step 6. If the tip of the
implant does not become visible in the incision, gently insert a forceps into
the incision (Figure 19). Flip the forceps over into your other hand (Figure
20).

Figure 19

Figure 20

Step 7. With a second pair of
forceps carefully dissect the tissue around the implant and grasp the implant
(Figure 21). The implant can then be removed.

Figure 21

Step 8. Confirm that the entire
implant, which is 4 cm long, has been removed by measuring its length. If a
partial implant (less than 4 cm) is removed, the remaining piece should be
removed by following the instructions. [See Removal of IMPLANON] If the woman would like to continue using IMPLANON, a new
implant may be inserted immediately after the old implant is removed using the
same incision [see Replacing IMPLANON].

Step 9. After removing the
implant, close the incision with a steri-strip and apply an adhesive bandage.

Step 10. Apply a pressure
bandage with sterile gauze to minimize bruising. The woman may remove the
pressure bandage in 24 hours and the small bandage in 3 to 5 days.

Replacing IMPLANON

Immediate replacement can be
done after removal of the previous implant and is similar to the insertion
procedure described in section 2.2 Insertion of IMPLANON.

The new implant may be inserted
in the same arm, and through the same incision from which the previous implant
was removed. If the same incision is being used to insert a new implant,
anesthetize the insertion site [for example, 2 mL lidocaine (1%)] applying it
just under the skin along the 'insertion canal.'

Follow the subsequent steps in
the insertion instructions [see Insertion of IMPLANON].

HOW SUPPLIED

Dosage Forms And Strengths

One IMPLANON package consists of a single implant
containing 68 mg etonogestrel that is 4 cm in length and 2 mm in diameter,
which is pre-loaded in the needle of a disposable applicator. The sterile
applicator containing the implant is packed in a blister pack.